Recalls / Class II
Class IID-0789-2017
Product
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
- Brand name
- Milrinone Lactate In Dextrose
- Generic name
- Milrinone Lactate
- Active ingredient
- Milrinone Lactate
- Route
- Intravenous
- NDCs
- 0338-6010, 0338-6011
- FDA application
- ANDA075834
- Affected lot / code info
- Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
Why it was recalled
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 90,450 bags
- Distribution pattern
- US and foreign countries: United Arab Emirates, Colombia, and Canada
Timeline
- Recall initiated
- 2017-05-15
- FDA classified
- 2017-05-18
- Posted by FDA
- 2017-05-24
- Terminated
- 2018-08-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0789-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.